NCT05385614

Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.

Conditions

• Depression
• Cognitive Impairment
• Cognitive Dysfunction
• Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	de:)press	Patients will receive de:)press for the duration of six weeks. They will be encourages to use the app at least three times a week, up to once per day.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-05-23
• Last updated: 2022-05-23

Locations

1 site across 1 country: Germany